Comparing associations between frailty and mortality in hospitalised older adults with or without COVID-19 infection: a retrospective observational study using electronic health records.

BACKGROUND: The aim of this study was to describe outcomes in hospitalised older people with different levels of frailty and COVID-19 infection. METHODS: We undertook a single-centre, retrospective cohort study examining COVID-19-related mortality using electronic health records, for older people (65 and over) with frailty, hospitalised with or without COVID-19 infection. Baseline covariates included demographics, early warning scores, Charlson Comorbidity Indices and frailty (Clinical Frailty Scale, CFS), linked to COVID-19 status. FINDINGS: We analysed outcomes on 1,071 patients with COVID-19 test results (285 (27%) were positive for COVID-19). The mean age at ED arrival was 79.7 and 49.4% were female. All-cause mortality (by 30 days) rose from 9 (not frail) to 33% (severely frail) in the COVID-negative cohort but was around 60% for all frailty categories in the COVID-positive cohort. In adjusted analyses, the hazard ratio for death in those with COVID-19 compared to those without COVID-19 was 7.3 (95% CI: 3.00, 18.0) with age, comorbidities and illness severity making small additional contributions. INTERPRETATION: In this study, frailty measured using the CFS appeared to make little incremental contribution to the hazard of dying in older people hospitalised with COVID-19 infection; illness severity and comorbidity had a modest association with the overall adjusted hazard of death, whereas confirmed COVID-19 infection dominated, with a sevenfold hazard for death.

Surgical fixation compared with cast immobilisation for adults with a bicortical fracture of the scaphoid waist: the SWIFFT RCT.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of surgical fixation with cast treatment and early fixation in adults with scaphoid waist fractures that fail to unite. DESIGN: Multicentre, pragmatic, open-label, parallel two-arm randomised controlled trial with an economic evaluation and a nested qualitative study. SETTING: Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013, with final follow-up in September 2017. PARTICIPANTS: Adults (aged ≥ 16 years) presenting within 2 weeks of injury with a clear, bicortical fracture of the scaphoid waist on plain radiographs. INTERVENTIONS: Early surgical fixation using Conformité Européenne-marked headless compression screws. Below-elbow cast immobilisation for 6-10 weeks and urgent fixation of confirmed non-union. MAIN OUTCOME MEASURES: The primary outcome and end point was the Patient-Rated Wrist Evaluation total score at 52 weeks, with a clinically relevant difference of 6 points. Secondary outcomes included Patient-Rated Wrist Evaluation pain and function subscales, Short Form questionnaire 12-items, bone union, range of movement, grip strength, complications and return to work. RESULTS: The mean age of 439 participants was 33 years; 363 participants were male (83%) and 269 participants had an undisplaced fracture (61%). The primary analysis was on 408 participants with valid Patient-Rated Wrist Evaluation outcome data for at least one post-randomisation time point (surgery, n = 203 of 219; cast, n = 205 of 220). There was no clinically relevant difference in the Patient-Rated Wrist Evaluation total score at 52 weeks: the mean score in the cast group was 14.0 (95% confidence interval 11.3 to 16.6) and in the surgery group was 11.9 (95% confidence interval 9.2 to 14.5), with an adjusted mean difference of -2.1 in favour of surgery (95% confidence interval -5.8 to 1.6; p = 0.27). The non-union rate was low (surgery group, n = 1; cast group, n = 4). Eight participants in the surgery group had a total of 11 reoperations and one participant in the cast group required a reoperation for non-union. The base-case economic analysis at 52 weeks found that surgery cost £1295 per patient more (95% confidence interval £1084 to £1504) than cast treatment. The base-case analysis of a lifetime-extrapolated model confirmed that the cast treatment pathway was more cost-effective. The nested qualitative study identified patients' desire to have a 'sense of recovering', which surgeons should address at the outset. LIMITATION: There were 17 participants who had initial cast treatment and surgery for confirmed non-union, which in 14 cases was within 6 months from randomisation and in three cases was after 6 months. Three of the four participants in the cast group who had a non-union at 52 weeks were not offered surgery. CONCLUSIONS: Adult patients with an undisplaced or minimally displaced scaphoid waist fracture should have cast immobilisation and suspected non-unions immediately confirmed and urgently fixed. Patients should be followed up at 5 years to investigate the effect of partial union, degenerative arthritis, malunion and screw problems on their quality of life. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67901257. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 52. See the NIHR Journals Library website for further project information.

Fracture of the scaphoid bone (one of eight small bones in the wrist) is common in young active people. It is caused by a fall on the hand or the hand being suddenly forced backwards. The usual treatment is to rest the wrist in a plaster cast for 6­10 weeks and allow the broken bone to heal. In 1 in 10 cases in which the fracture is treated in a plaster cast, the bone does not heal and an operation is needed. In the operation, the broken bone is held still with a screw. In the last few years, it has become more common to fix the broken bone with a screw in the first few days after injury, instead of resting the wrist in a plaster cast. It is not clear if fixing the bone early with a screw, compared with resting the wrist in a cast, gives better outcomes for patients and if one treatment is better value for money for the NHS. In this study, 439 adult patients agreed either to have surgery to hold the broken scaphoid with a special screw or to have the wrist held still in a plaster cast (with surgery offered after 6 weeks to those who were still not healed). The decision about which treatment to use was made using randomisation, which is similar to tossing a coin. Patients reported their own wrist pain and function at 6, 12, 26 and 52 weeks. Information was also collected on general health, bone healing, grip strength and range of movement, complications from treatment and costs. No important differences were found in patients' wrist pain and function at 52 weeks. The bone did not heal properly in four patients in the surgery group or in nine patients in the plaster cast group at 52 weeks. For one of these patients in the surgery group and four of these patients in the plaster cast group, the bone did not join at all. Eight patients in the surgery group had further surgery following their initial operation to fix their wrist, and one patient in the cast group required repeated surgery because the bone did not join at all. The overall cost of treating with a plaster cast was lower than that of early surgery. Therefore, the findings of the study suggest that a plaster cast should be used initially and that the bone should be immediately fixed with a screw if it does not heal.

Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less. METHODS: This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1-2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing. FINDINGS: Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2-14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference -2·1 [95% CI -5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group). INTERPRETATION: Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) protocol: a pragmatic multi-centre randomised controlled trial of cast treatment versus surgical fixation for the treatment of bi-cortical, minimally displaced fractures of the scaphoid waist in adults.

BACKGROUND: A scaphoid fracture is the most common type of carpal fracture affecting young active people. The optimal management of this fracture is uncertain. When treated with a cast, 88 to 90 % of these fractures unite; however, for the remaining 10-12 % the non-union almost invariably leads to arthritis. The alternative is surgery to fix the scaphoid with a screw at the outset. METHODS/DESIGN: We will conduct a randomised controlled trial (RCT) of 438 adult patients with a "clear" and "bicortical" scaphoid waist fracture on plain radiographs to evaluate the clinical effectiveness and cost-effectiveness of plaster cast treatment (with fixation of those that fail to unite) versus early surgical fixation. The plaster cast treatment will be immobilisation in a below elbow cast for 6 to 10 weeks followed by mobilisation. If non-union is confirmed on plain radiographs and/or Computerised Tomogram at 6 to 12 weeks, then urgent surgical fixation will be performed. This is being compared with immediate surgical fixation with surgeons using their preferred technique and implant. These treatments will be undertaken in trauma units across the United Kingdom. The primary outcome and end-point will be the Patient Rated Wrist Evaluation (a patient self-reported assessment of wrist pain and function) at 52 weeks and also measured at 6, 12, 26 weeks and 5 years. Secondary outcomes include an assessment of radiological union of the fracture; quality of life; recovery of wrist range and strength; and complications. We will also qualitatively investigate patient experiences of their treatment. DISCUSSION: Scaphoid fractures are an important public health problem as they predominantly affect young active individuals in the more productive working years of their lives. Non-union, if untreated, can lead to arthritis which can disable patients at a very young age. There is a rapidly increasing trend for immediate surgical fixation of these fractures but there is insufficient evidence from existing RCTs to support this. The SWIFFT Trial is a rigorously designed and adequately powered study which aims to contribute to the evidence-base to inform clinical decisions for the treatment of this common fracture in adults. TRIAL REGISTRATION: The trial is registered with the International Standard Randomised Controlled Trial Register ( ISRCTN67901257 ). Date registration assigned was 13/02/2013.

Delay between symptom onset and clinic attendance following TIA and minor stroke: the BEATS study.

BACKGROUND: rapid specialist assessment of patients with transient ischaemic attack (TIA) reduces the risk of recurrent stroke. National guidelines advise that high-risk patients are assessed within 24 h and low-risk patients within 7 days. AIM: to quantify delay and map pathways taken by patients from symptom onset to specialist assessment. DESIGN: retrospective cohort study. SETTING: rapid access TIA clinic. METHODS: structured interviews with 278 patients newly diagnosed with TIA (222) or minor stroke (56), and examination of medical records. RESULTS: of the 133 high-risk TIA patients, 11 (8%) attended the clinic within 24 h of symptom onset; of the 89 low-risk TIA patients, 47 (53%) attended within 7 days. Median delay between symptom onset and seeking help from a healthcare professional (HCP) was 4.0 h (IQR 0.5, 41.3). Delay was less if symptoms were correctly interpreted but not reduced by a publicity campaign (FAST) to encourage an urgent response. Most patients (156, 56%) first contacted a general practitioner (GP) and 46 (17%) called an ambulance or attended the emergency department. Over a third (36%) had a second consultation with an HCP before attending the clinic, and this was more likely in those presenting to paramedics, out of hours GP services or optometry. Time to clinic attendance was less if an emergency pathway was used and greater if patients were seen by a second HCP. CONCLUSIONS: factors contributing to delay include incorrect interpretation of symptoms and failure to invoke emergency services. Delays after presentation could be addressed by direct referral by out of hours services, paramedics and optometrists.

Identifying people with type 2 diabetes and those at risk: lessons from the measure your waist (MY-WAIST) mixed-methods study in UK primary care.

AIMS: This paper focuses mainly on explanations and lessons from a research-based programme for identifying undiagnosed type 2 diabetes and high risk. In addition to outlining key quantitative findings, we specifically aim to explore reasons for low uptake from the perspective of primary care staff involved. METHODS: The MY-WAIST study was conducted in UK primary care and included the use of oral glucose tolerance tests (OGTTs) and waist measurement. Qualitative data from interviews with healthcare providers and records of meetings were analysed thematically. RESULTS: The key quantitative finding was low uptake of the assessments offered (8.6% overall, 2.6% in inner-city locations with high South Asian residency). In addition to confirming patient-reported barriers including those associated with OGTTs, qualitative findings highlighted a number of primary care provider barriers, including limited staff capacity. Interviewees suggested that those who attended were typically the 'worried well' rather than those from hard-to-reach groups. CONCLUSIONS: Implications discussed include the impact of low uptake on the usefulness of the quantitative data obtained, and lessons relevant to research design. Relevance to current guidance regarding early identification strategies is discussed and the importance of addressing the needs of less accessible groups is highlighted.

Junior doctors and patient safety: evaluating knowledge, attitudes and perception of safety climate.

INTRODUCTION: Engagement of junior doctors in patient safety initiatives is high on the national agenda, but there is a lack of studies evaluating patient safety attitudes among junior doctors. METHODS: The Junior Doctor-Patient Safety Attitudes and Climate Questionnaire is a multidimensional scale created using items from already-validated scales and inclusion of new items based on further review. It consists of three subscales: 'knowledge and training' (10 items), 'attitudes to patient safety' (15 items) and 'perception of workplace safety climate' (15 items). This was disseminated to foundation trainees, general practice trainees and hospital core and speciality trainees via the Deanery distribution lists and responses were collected anonymously. RESULTS: A total of 527 complete responses were collected; although self-declared knowledge in patient safety concepts was high, there was less declared understanding of a 'high reliability organisation' (74% no/unsure) and the concept of active failures/latent conditions (60% no/unsure). The greatest agreement was demonstrated for the statement 'Even the most experienced and competent doctors make errors' (p<0.01). However, more senior trainees and surgical trainees (vs medical trainees) demonstrated greater agreement with 'Medical error is a sign of incompetence' (p<0.01). More junior trainees demonstrated greater agreement with 'Management is more interested in meeting performance targets than focusing on patient safety issues' (p<0.01). CONCLUSIONS: This study demonstrates subtle differences in attitudes to patient safety among junior doctors of different grades and specialities. These should be taken into account when designing interventions to improve patient safety education and culture among junior doctors.

A comparison of cost per case detected of screening strategies for Type 2 diabetes and impaired glucose regulation: modelling study.

BACKGROUND: To determine a cost per case detected for different screening strategies for both Type 2 diabetes alone and in combination with impaired glucose regulation. METHODS: Bayesian framework modelling study using data from the ADDITION-Leicester screening study in UK multi-ethnic primary care setting. There were 5794 people aged 40-75 years (77.4% white European; 22.6% south Asian) without previously known diabetes. We compared 212 screening strategies including blood tests, a computer practice data score and a risk score, as part of a multi-stage process that all used an oral glucose tolerance test as the diagnostic test. Simulation models were created using sensitivity estimates for the expected cost per case. RESULTS: The estimated costs per case identified for the 18 most sensitive strategies varied from £457 to £1639 (€526-1886, for £1=€1.15) for diabetes and £148-913 (€170-1050) for both diabetes and impaired glucose regulation. The lowest costing diabetes strategies ranged from £457 to £523 (€526-601) involving a two-stage screening strategy, a non-invasive risk stratifying tool followed by a blood test, producing sensitivities ranging from 67.1 to 82.4%. CONCLUSION: Screening a population using a non-invasive risk stratification tool followed by a screening blood test is the most cost-effective method of screening for diabetes and abnormal glucose tolerance.

Influences on the uptake of diabetes screening: a qualitative study in primary care.

BACKGROUND: To address the increasing global prevalence of type 2 diabetes healthcare organisations have been contemplating different screening and intervention strategies. Patient acceptability is a key criterion of a screening programme. AIM: To explore the perspectives of those invited to attend the MY-WAIST screening study for type 2 diabetes, particularly explanations for attending or not, and views on the specific screening strategy. DESIGN AND SETTING: Qualitative study of 11 general practices in Leicestershire, UK. METHOD: Semi-structured interviews were conducted with 24 individuals (40-69 years) invited to attend the MY-WAIST screening study, comprising 13 who attended and 11 who did not attend the screening. Additional data included reply slips from 73 individuals who declined the offer of screening. Analysis was informed by the constant comparative method. RESULTS: Two categories of influence on the decision about attending screening emerged. 1) Beliefs about type 2 diabetes candidacy and type 2 diabetes was more common among those who had attended; lack of perceived severity of type 2 diabetes was more common among those who did not attend. 2) Practical aspects about the screening strategy: the lengthy, early morning screening appointments were a barrier to uptake; screening attendees found the procedure largely acceptable. Pre-screening waist self-measurement was more memorable than the remainder of the risk-score calculation; neither impacted on uptake. CONCLUSION: The barriers to screening uptake highlighted contribute to current debates about different screening and diagnostic tests for type 2 diabetes and future risk of type 2 diabetes. The findings are useful for those contemplating implementation of screening programmes for identifying type 2 diabetes and pre-diabetes.

Patient feedback in revalidation: an exploratory study using the consultation satisfaction questionnaire.

BACKGROUND: Revalidation is the UK process for the review of doctors to ensure they are fit to practise. Revalidation will include patient feedback. AIM: To investigate the role of patient feedback on GPs' consultations in revalidation. DESIGN AND SETTING: Cross-sectional survey of patients consulting 171 GPs. METHOD: A total of 6433 patients aged 16 years or over completed the consultation satisfaction questionnaire (CSQ). Generalisability analysis was undertaken, scale scores calculated, and outliers identified using two and three standard deviations from the mean as control limits. Comments made by patients were categorised into positive, neutral, or negative. RESULTS: After averaging each scale for each doctor, mean scores (standard deviation), out of a possible score of 100, were: general satisfaction 78.1 (7.2); professional care 82.1 (6.1); relationship 71.2 (7.1); perceived time 65.7 (7.6). A D-study (which enables estimation of the reliability from 0-1 of the CSQ scores for different numbers of responders for each doctor), indicated that ratings by 19 patients would achieve a generalisability coefficient of 0.80 for the combined score. Fifteen GPs had one or more scale scores below two standard deviations of the mean. Comments were more often negative for GPs with scores below two standard deviations of the mean. CONCLUSION: Most patients of most GPs are satisfied with their experience of consultations, and ways to make patient feedback formative for these doctors is required. For a few GPs, most patients report some dissatisfaction. Patient feedback may identify doctors who need educational support and possibly remediation, but agreed questionnaire score thresholds are required, and agreement is needed on the weight to be attached to patient experience in comparison with other aspects of performance.

The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data.

BACKGROUND: Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM) and its major vascular sequelae. Metabolic syndrome (MetS) comprises a constellation of factors that increase the risk of cardiovascular disease (CVD) and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data. METHODS: Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up. RESULTS: 82 participants (44% male, 22% South Asian) were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42) and control groups (n = 40). Median age was 63 years (IQR 57 - 67), mean waist size 106 cm (SD ± 11), and prescribing of statins and anti-hypertensives was 51% in each case. CONCLUSION: Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.

Management of smokers motivated to quit: a qualitative study of smokers and GPs.

BACKGROUND: The National Institute for Health and Clinical Excellence (NICE) guidelines state that GPs should manage smokers motivated to quit by offering referral to Stop Smoking Services (SSS) and that nicotine addiction treatment (NAT) should be offered only to those who decline referral. OBJECTIVE: To explore how smokers motivated to quit are managed in the GP consultation, specifically how treatment and referral are negotiated from the perspectives of both parties. METHODS: Twenty patients, identified in a consultation with their GP as motivated to quit smoking, and 10 participating GPs were interviewed. Interviews were recorded, transcribed, coded and analysed using the framework approach. RESULTS: Three strategies (treatment and follow-up by the GP, referral to SSS without treatment and immediate treatment with referral for follow-up) were evidenced in patient and GP accounts. Most patients were satisfied with their management and how this was negotiated, but some expressed surprise or dissatisfaction with lack of immediate treatment and questioned the need for referral to SSS. GPs welcomed the availability of SSS but some felt it important that they themselves also continued to support a quit attempt. Several saw advantages in offering NAT at the time the patient was motivated to stop. CONCLUSIONS: Smokers appear less convinced than GPs about the value of referral to SSS, although these differences may be resolved through negotiation. An alternative strategy to that proposed by NICE, which may be more acceptable to some smokers, is immediate treatment with subsequent support from SSS.

Caffeine intake during pregnancy, late miscarriage and stillbirth.

Caffeine is a commonly consumed drug during pregnancy with the potential to affect the developing fetus. Findings from previous studies have shown inconsistent results. We recruited a cohort of 2,643 pregnant women, aged 18-45 years, attending two UK maternity units between 8 and 12 weeks gestation from September 2003 to June 2006. We used a validated tool to assess caffeine intake at different stages of pregnancy and related this to late miscarriage and stillbirth, adjusting for confounders, including salivary cotinine as a biomarker of smoking status. There was a strong association between caffeine intake in the first trimester and subsequent late miscarriage and stillbirth, adjusting for confounders. Women whose pregnancies resulted in late miscarriage or stillbirth had higher caffeine intakes (geometric mean = 145 mg/day; 95% CI: 85-249) than those with live births (103 mg/day; 95% CI: 98-108). Compared to those consuming < 100 mg/day, odds ratios increased to 2.2 (95% CI: 0.7-7.1) for 100-199 mg/day, 1.7 (0.4-7.1) for 200-299 mg/day, and 5.1 (1.6-16.4) for 300+ mg/day (P (trend) = 0.004). Greater caffeine intake is associated with increases in late miscarriage and stillbirth. Despite remaining uncertainty in the strength of association, our study strengthens the observational evidence base on which current guidance is founded.

Limited role of multi-attribute utility scale and SF-36 in predicting management outcome of heavy menstrual bleeding.

OBJECTIVE: To compare the value of SF36v2 versus multi-attribute utility score (MAS) for predicting treatment outcome in heavy menstrual bleeding (HMB). STUDY DESIGN: Longitudinal observational study, in an outpatient service of a large UK teaching hospital. 193 women took part. Women were asked to complete SF36v2 and a multi-attribute utility score (MAS) for menorrhagia before the first consultation. Patient management was determined through an evidence based guideline and blind to their response to the questionnaire. Treatment outcome at 8 months was examined in relation to the physical (PCS) and mental (MCS) health summary scales of SF36v2 and to MAS. RESULTS: At study entry equal numbers of patients, 179 (93%), returned usable responses for SF36v2 and the multi-attribute scale; 178 (92%) returned both. Baseline SF36v2 scores for role physical, bodily pain, social functioning and mental health were significantly lower (p<0.05) for the group of women who finally required surgery, but the difference in PCS or MCS was not statistically significant. The mean MAS score for those who did not need surgery was 50.7, and for those who needed surgery following failed medical treatment was 35.06. The difference was statistically significant (p<0.001, 95% CI 7.47-23.82). Using logistic regression analysis there was a statistically significant association between baseline MAS but not MCS or PCS and the need for surgery. However, there was considerable overlap between treatment groups. CONCLUSIONS: MAS may be a better predictor of management outcome compared to SF36v2 for HMB; but its utility for the individual patient is limited.

Is having a family history of type 2 diabetes or cardiovascular disease a predictive factor for metabolic syndrome?

AIMS: To determine whether a first degree family history (FH) of diabetes and/or a first degree FH of cardiovascular disease (CVD), can predict prevalent cases of metabolic syndrome (MetS). Also, to establish if the association is different for South Asians compared to White Europeans, and for obese compared to non-obese individuals. METHODS: Cross-sectional data were analysed for a mixed-ethnic cohort of 3094 at-risk individuals, aged 40-75 years (29% South Asian), who were screened in Leicestershire (UK) for undiagnosed type 2 diabetes using an oral glucose tolerance test. Logistic regression was used to assess the relationship between FH and prevalent MetS, including adjustment for potential confounders. RESULTS: Prevalence of MetS was 39%. Adjusted odds ratios (OR) showed that only a FH of CVD (OR 1.41, 95%CI: 1.18-1.68, p<0.001) was significantly associated with prevalent MetS. Interaction analysis showed no effect modification for obesity and ethnicity. We did not find any association for a FH of diabetes. CONCLUSIONS: These findings suggest that a first degree FH of CVD predicts prevalent cases of MetS in a mixed-ethnic population. Evidence of an association may help to identify individuals who should be targeted for screening and early prevention of type 2 diabetes and CVD.

An integrated care pathway for menorrhagia across the primary-secondary interface: patients' experience, clinical outcomes, and service utilisation.

BACKGROUND: "Referral" characterises a significant area of interaction between primary and secondary care. Despite advantages, it can be inflexible, and may lead to duplication. OBJECTIVE: To examine the outcomes of an integrated model that lends weight to general practitioner (GP)-led evidence based care. DESIGN: A prospective, non-random comparison of two services: women attending the new (Bridges) pathway compared with those attending a consultant-led one-stop menstrual clinic (OSMC). Patients' views were examined using patient career diaries, health and clinical outcomes, and resource utilisation. Follow-up was for 8 months. SETTING: A large teaching hospital and general practices within one primary care trust (PCT). RESULTS: Between March 2002 and June 2004, 99 women in the Bridges pathway were compared with 94 women referred to the OSMC by GPs from non-participating PCTs. The patient career diary demonstrated a significant improvement in the Bridges group for patient information, fitting in at the point of arrangements made for the patient to attend hospital (ease of access) (p<0.001), choice of doctor (p = 0.020), waiting time for an appointment (p<0.001), and less "limbo" (patient experience of non-coordination between primary and secondary care) (p<0.001). At 8 months there were no significant differences between the two groups in surgical and medical treatment rates or in the use of GP clinic appointments. Significantly fewer (traditional) hospital outpatient appointments were made in the Bridges group than in the OSMC group (p<0.001). CONCLUSION: A general practice-led model of integrated care can significantly reduce outpatient attendance while improving patient experience, and maintaining the quality of care.

Cytokine imbalance in infants receiving extracorporeal membrane oxygenation for respiratory failure.

BACKGROUND: It is likely that the imbalance between the pro- and anti-inflammatory cytokines will determine the outcome in infants with severe respiratory failure receiving extracorporeal membrane oxygenation (ECMO). AIMS: We determined if there was an imbalance between pro- and anti-inflammatory cytokines in serial bronchoalveolar lavage (BAL) fluid obtained from survivors and non-survivors of ECMO. METHODS: We therefore measured the cellular changes and the molar ratios of pro-inflammatory and anti-inflammatory cytokines in serial BAL fluid obtained from survivors and non-survivors of ECMO. Fifteen infants surviving ECMO (median age 1 day, range 1-120) and 7 who did not (28 days, range 1-402) were studied. RESULTS: In the lungs of survivors, the increased proportion of airway neutrophils at presentation decreased with time and was matched by a parallel increase in percent alveolar macrophages as the infants' condition improved. The pro- and anti-inflammatory pulmonary cytokine ratios were static in the survivors. In the non-survivors, the ratio of tumour necrosis factor-alpha (TNF-alpha) against soluble TNF-receptor 1 (sTNF-R1) and soluble TNF receptor 2 (sTNF-R2) was increased at days 2-3 when compared to the survivors, but the molar ratio interleukin-1beta (IL-1beta)/soluble IL-1 receptor antagonist (sIL-1RA) was largely undetectable due to undetectable IL-1beta. CONCLUSIONS: These data suggest that the infants who survive ECMO resolve their pulmonary inflammation and that in non-survivors the ratio of TNF-alpha against its receptor antagonists is increased and is associated with a poor outcome. Furthermore, this group of infants were unable to produce significant concentrations of IL-1beta.

International variation in histologic grading is large, and persistent feedback does not improve reproducibility.

Histologic grading systems are used to guide diagnosis, therapy, and audit on an international basis. The reproducibility of grading systems is usually tested within small groups of pathologists who have previously worked or trained together. This may underestimate the international variation of scoring systems. We therefore evaluated the reproducibility of an established system, the Banff classification of renal allograft pathology, throughout Europe. We also sought to improve reproducibility by providing individual feedback after each of 14 small groups of cases. Kappa values for all features studied were lower than any previously published, confirming that international variation is greater than interobserver variation as previously assessed. A prolonged attempt to improve reproducibility, using numeric or graphical feedback, failed to produce any detectable improvement. We then asked participants to grade selected photographs, to eliminate variation induced by pathologists viewing different areas of the slide. This produced improved kappa values only for some features. Improvement was influenced by the nature of the grade definitions. Definitions based on "area affected" by a process were not improved. The results indicate the danger of basing decisions on grading systems that may be applied very differently in different institutions.